SCIENT'X TO BEGIN U.S. DISCOCERV TRIALS

Scient'x USA will submit an investigational device exemption application to begin clinical trials of its Discocerv cervical disc replacement in the fourth quarter of this year.

The Discocerv consists of titanium alloy endplates embedded with ceramic bearing components. The ceramic-on-ceramic bearing technology is used in order to eliminate wear related complications presented by other materials involved in total disc replacement. Anatomically designed endplates provide intimate contact between the prosthesis and vertebral bodies, leading to excellent primary anchorage of the device. The Discocerv also features a pre-defined lordotic angle to restore the natural curvature of the spine.

"The young age of disc patients requires that a replacement may be expected to last for 40 years," said Scient'x USA President Craig Corrance. "Concerns over osteolysis from polyethylene debris indicate that it is not acceptable as a bearing material in the long term. Indeed, the state of the art for joint replacement in the young active patient is ceramic surfaces. We believe it is even more critical in the disc."